Feasibility Study for the Generation of Organoids From Male Breast Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Tumor tissue samples collected
研究概览
简要总结
It is believed that the use of organoids derived from male breast tumors can be of fundamental support for the definition of the molecular mechanisms underlying the onset of the tumor. Furthermore, the development of such preclinical models could be of significant support for the identification of specific personalized and ad hoc therapeutic treatments for male pathology.
详细描述
The main objective of the project is to set up at least 5 organoid cultures of male breast cancer derived from patients who have undergone surgery. This study will allow to define the success rate in the generation of organoids.
A secondary objective is to verify the correspondence between the organoids generated and the tumor tissue of origin.
In this regard, broad-spectrum molecular investigations will be carried out, such as mutational analysis of DNA through Whole Exome Sequencing (WES), gene expression profiles through RNA sequencing (RNAseq) and small RNA sequencing, proteomic and metabolomic analysis of both the tumors of origin and the cultures of derived organoids (PDO).
Furthermore, to verify the functional correspondence of the organoids with the tumor of origin, in vitro viability tests will be carried out by treating the PDOs with the same drugs administered to the patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged >18 years
- •Patients with histologically confirmed breast cancer with or without synchronous metastases, who will undergo the relevant surgical intervention
- •Adequate biological material to be able to carry out the analyses described above
- •Signing of the relevant informed consent form
排除标准
- •not present
结局指标
主要结局
Tumor tissue samples collected
时间窗: 36 months
Samples of tumor and peri-tumor tissue from the same patient, obtained at the time of surgery for the preparation of organoids to verify the functional correspondence of the organoid cultures obtained from the patients, with the tumors of origin. The organoids will be treated in vitro with doses equivalent to the plasma levels of the drugs administered to the patients, and the viability of the organoids will be assessed through ATPlite assays. Subsequently, the viability data will be compared with the response data of the patients.
次要结局
未报告次要终点